Actively Recruiting
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
Led by Duke University · Updated on 2025-08-19
76
Participants Needed
2
Research Sites
169 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is single-center cross-sectional mechanistic study in lean and obese children with moderate-severe asthma, followed by a randomized, SHAM-controlled trial of Inspiratory Training (IT). The primary outcome is to describe the contributions of inspiratory muscle dysfunction (IMD) and Small Airway Dysfunction (SAD) to obesity-related versus non-obesity-related asthma. The study will involve training (IT) for 8 weeks at three intensity levels (SHAM, low and high). Target dose: 150 inspirations three times weekly. The population includes 6 to 17-year-old children with moderate to severe asthma and with a body mass index qualifying as normal habitus (BMI 5th to 84th CDC percentile) or obese habitus (≥95th percentile BMI and less than 170% of the 95th CDC percentile). Participants will be involved for 10 weeks. The investigators will use analysis of covariance (ANCOVA) to estimate and test the difference in mean values of baseline measures between obese and non-obese cohorts. Covariates will include age, sex (male/female), race/ethnicity, baseline asthma severity (NAEPP step 2 vs ≥3), and atopy status
CONDITIONS
Official Title
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 17 years
- Clinician-diagnosed asthma
- Currently using two or more controller medications for asthma
- Body mass index (BMI) in the normal range (5th to 84th CDC percentile) or obese (≥95th percentile and less than 170% of the 95th percentile)
You will not qualify if you...
- Asthma Control Test (ACT) score less than 17
- History of intubation for asthma
- Forced expiratory volume in 1 second (FEV1) less than 50% of predicted at enrollment
- Currently pregnant
- Legal guardian unable to consent in English or Spanish
- Any major chronic illness that would interfere with participation
- Younger than 6 years old
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Duke Health Center Creekstone
Durham, North Carolina, United States, 27703
Actively Recruiting
2
Duke Healthy Lifestyles Clinic
Durham, North Carolina, United States, 27704
Actively Recruiting
Research Team
J
Jason Lang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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